New Indirect Calorimetry Device for Energy Expenditure Measurement

NCT02024958 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 182

Last updated 2017-10-26

No results posted yet for this study

Summary

Energy expenditure (EE) in critically ill patients is highly variable depending on the initial severity of the disease and treatments. Clinicians need to measure EE by indirect calorimetry (IC) to optimize nutritional support. IC devices available on the market have insufficient accuracy for clinical and research use. A new IC is being developed to meet these needs.

Objectives: Validation of a reliable and easy-to-use IC device.

Primary objective:

• Accuracy of EE measurements (kcal/d measured over 30 min) of the new and the reference IC devices in intubated ICU patients on mechanical ventilation

Secondary objectives:

* Accuracy of EE measurements in ICU patients of spontaneous breathing
* Accuracy of EE measurement during \~30 min. vs. the sum of 6 periods of 60 min/12 hrs
* Accuracy of EE measurements in ICU patients on non-invasive mechanical ventilation

Design: Prospective, controlled, observational multicenter study.

Subjects: 182 ICU patients.

Conditions

  • Acute Respiratory Failure

Sponsors & Collaborators

  • Helse-Bergen HF

    collaborator OTHER
  • University of Lausanne Hospitals

    collaborator OTHER
  • Medical University of Vienna

    collaborator OTHER
  • Rabin Medical Center

    collaborator OTHER
  • Karolinska University Hospital

    collaborator OTHER
  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Claude Pichard, Prof · University Hospital, Geneva

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-03-31
Completion
2018-07-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02024958 on ClinicalTrials.gov